Kornimate/medical-research-clean huggingface dataset:
corticosteroid-induced lipodystrophy and adipokines

Conditions: Lipodystrophy

Summary: hypothesis: systemic therapy with corticosteroid induces morphological changes (e.g., moon face, buffalo neck) called lipodystrophy (ld). we hypothesize that this ld is associated with variation of adipocytokines (e.g., adiponectin, leptine, il6) levels primary objective: to show a 50% decrease in adipocytes adiponectin's expression in patients who developed ld versus those who did not developed ld during the first 3 months of a systemic therapy with corticosteroids secondary objectives: to look for differences in the mrna expression of 11bhsd1, srebp1c and pparg in fat samples of patients before and after treatment with systemic corticosteroids and between ld+ and ld-patients to compare the fat morphology before and after treatment with glucosteroids

design: monocentric, cross-sectional analytical study subjects: 32 hiv-free and cushing disease-free adult patients for whom a prolonged treatment (³3months) with glucosteroids (³ 0.5 mg/kg/day) is initiated methods: at treatment initiation and 3 months after: comparison of fat sample mrna expression of adipokines (adiponectin, leptin, il6, tnfa), 11bhsd1, srebp1c and pparg, fat morphology and seric concentrations of adiponectin, leptin, il6, stnfr1 between patients ld+ and patients ld-. the diagnosis of ld will be performed by 3 experts using patients photographs aims of this study: * to gain a better understanding of the pathophysiology of glucosteroids-induced ld * to compare this pathophysiology to the one of hiv-associated ld for which the hypothesis of a local, cellular, hypercorticism has been put forward and for which related treatment have been prescribed.

Eligibility criteria:
inclusion criteria: * adult patient * starting therapy with prednisone * corticosteroid therapy lasting more than 3 months * baseline prednisone dosage \>= 0.5 mg/kg/d exclusion criteria: * cushing disease * hiv +pregnancy * recent weight lost (\> 5% of the usual weight) * therapy with glucocorticosteroids during the past 6 months

Keywords: lipodystrophy adipokines glucocorticoids patients with glucocorticoids
evaluation of the clinical outcomes of the total knee ps prosthesis implanted with the use of inertial sensors

Conditions: Prosthesis Durability

Summary: evaluate the clinical outcome of the implantation of a specific primary tka model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;


Eligibility criteria:
inclusion criteria: 1. male and female subjects 50 years of age or older and less than 85 years of age (\>50 and \<85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes: * to. primary or secondary osteoarthritis * b. collagen disorders and/or avascular necrosis of femoral condyle * c. moderate valgus, varus or flexion deformities (hka between ± 10°, flexion contracture \<10°) - 2. patients consent and able to complete scheduled study procedures and follow-up assessments. 3. patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee. exclusion criteria: * simultaneous participation in other studies * patients not capable of understanding and wanting and therefore unable to sign the informed consent * patients who have already undergone hip or ankle arthroplasty, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases.
nafamostat efficacy in phase 3 registrational crrt study

Conditions: Acute Kidney Injury

Summary: a prospective, randomized, placebo-controlled clinical study to investigate the safety and efficacy of niyad (nafamostat mesylate) for anticoagulation of extracorporeal blood circulating through a dialysis filter in patients undergoing crrt who cannot tolerate heparin or are at higher risk for bleeding.

patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. continuous renal replacement therapy (crrt) allows a more gentle continual dialysis, more similar to regular kidney function. anticoagulation of the crrt circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in south korea and japan for anticoagulation of the crrt circuit. for patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the crrt circuit as the short half-life should minimize patient exposure. the primary objective of this study is to measure the anticoagulation efficacy of niyad in the crrt circuit versus placebo. evaluation of the safety of niyad in patients undergoing crrt versus placebo will also be performed.

Eligibility criteria:
inclusion criteria: * patients requiring crrt or undergoing crrt initiated within the prior 48 hours * patients who cannot tolerate heparin or are at high risk of bleeding exclusion criteria: * patients weighing less than 50 kg * patients receiving systemic anticoagulation * patients with active bleeding

Keywords: continuous renal replacement therapy anticoagulation
salivary gland transplantation in the treatment of dry eye in patients with stevens-johnson syndrome.

Conditions: Symblepharon; Dry Eye; Ocular Surface Disease; Transplantation

Summary: the purpose of this study is to evaluate salivary gland and labial mucous membrane transplantation in patients with severe symblepharon and dry eye secondary to stevens-johnson syndrome (sjs).

this study was performed to evaluate the use of salivary gland and labial mucous membrane transplantation in patients with severe symblepharon and dry eye secondary to sjs. labial mucous membrane and salivary gland transplantation showed to be a good option in the treatment of severe symblepharon and dry eye secondary to sjs. labial mucous membrane, salivary glands, symblepharon, entropion, transplantation, graft.

Eligibility criteria:
inclusion criteria: * only patients with poor visual acuity, less or equal to 20/200, and schirmer i test equal to zero. * eyes with symblepharon or ankyloblepharon that did not allow the placement of a schirmer test strip will be consider not measurable. exclusion criteria: * active infection and corneal melting or perforation.

Keywords: labial mucous membrane symblepharon dry eye stevens -johnson syndrome salivary gland ocular surface disease transplantation
psyhosomatic medicine in oncologic and cardiac disease study

Conditions: Acute Myocardial Infarction; Tako Tsubo Cardiomyopathy; Breast Cancer

Summary: psychological processes play a complex role in the pathophysiology of many diseases. however, the body and emotional perception of patients and the relationship between dreams and disease still need to be investigated. the investigators planned an observational and controlled research aimed at assessing some previously unaddressed baseline psychological characteristics and their changes at 1 and 5 years after a short-term psychotherapy in carefully characterised patients with heart or oncologic diseases . the patients that will be enrolled are: * 50 patients ≤ 75 year old with acute myocardial infarction; * 30 patients ≤ 75 year old with tako-tsubo syndrome; * 50 women ≤ 75 year old, recently operated on breast cancer: * 90 control subjects of the same age and gender of the enrolled patients, without relevant pathologies during the last 10 years. relevant pathologies are defined as those that required a hospitalisation or a long-lasting medical therapy. at the enrolment all the subjects will undergo a complete medical evaluation, and the following psychometric tests: self-evaluation test, social support questionnaire, beck depression inventory ii (bdi ii), macnew heart disease health-related quality of life questionnaire, state-trait anxiety inventory (stai), state-trait anger expression inventory (staxi 2). in two distinct following meetings, an open questionnaire exploring the body and emotional perception, and another exploring past and recent dreams, will be administered. the same evaluation will be done for the healthy subjects. after the initial evaluation, all the patients will be given the choice to start a short-term psychotherapy lasting 6 months on top of medical therapy or to continue classic medical therapy only. healthy subjects will be not offered the possibility to follow psychotherapy. at first year of follow-up, the battery of psychometric test, and the two questionnaires exploring the body and emotional perception, and changes and characteristics of dreams during the psychotherapy, will be re-administered. the following data will be evaluated: psychological characteristics at follow-up. incidence of new relevant medical events quality of life relationship between psychological characteristics and health status, and quality of life at 5 year follow-up psychometric tests and the clinical data will be evaluated in all the groups.


Eligibility criteria:
inclusion criteria: * patients within one week from an acute myocardial infarction treated with primary or urgent pci * patients within one week from the onset of tako tsubo cardiomyopathy. * patients with a diagnosis of breast cancer in the preceding six months * age and sex matched control subjects without relevant medical pathologies in the preceding 10 years exclusion criteria: * cognitive impairment * refusing the enrolment
molecular pet imaging and plasma biomarkers in alzheimer´s disease and other neurodegenerative diseases

Conditions: Alzheimer´s Disease

Summary: multi-modal pet tracer study with the aim of studying the time course of regional deposition of tau in brain of subjects with high risk of being carriers of autosomal dominant alzheimer´s disease and sporadic early onset and late onset alzheimer´s disease patient (eoad, load) in tertiary memory clinic cohort in relation to mri brain changes, plasma biomarker levels and cognitive performance.

multi-pet /mri studies , fluid biomarkers (csf, plasma) analysis, neuropsychological testing is performed in subjects carriers and non-carriers of different app, ps autosomal dominant ad mutatation. both presymptomatic and symptomatic carriers and non-carriers are recruited (age range -30 to +15 years from first clinical symptoms). for comparison also a group of healthy eldersly as well as patients undergoing memory assessment with diagnosis of mild cognitive impairment (amyloid negative /amyloid positive) and diagnosis sporadic alzheimer´s diases are recruited from karolinska memory clinic and undergoing similar multi-pet/mri studies , fluid biomarker analysis, neuropsycholigal testing. the aim is to describe the evolution and spreading of tau in brain in alzheimer continuum and compare with other pathological markers with aim of develop new diagnostic markers and therapeutic targets.

Eligibility criteria:
inclusion criteria: a)belonging to families with known familial form of alzheimer´s disease b) patient undergoing memory assessent at memory clinic with diagnosis mild cognitive impairment (mci), alzheimer´s disease c)healthy elderly cognitive normal - exclusion criteria: cancer and other serious disease
safety and efficacy study of cnop chemotherapy in diffuse large b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: the purpose of this study is to determine whether mitoxantrone hydrochloride liposome injection plus cyclophosphamide,vincristine and prednison(cnop)is safe and effective in the treatment of diffuse large b cell lymphoma.

mitoxantrone hydrochloride liposome injection is a kind of anthraquinone compounds, and its antineoplastic effect has been viewed in preclinical tests. the investigator´s phaseⅰstudy has shown that the drug´s toxicity is manageable and the tolerable does is 20 mg/m2. the purpose of this study is to determine whether mitoxantrone hydrochloride liposome injection plus cyclophosphamide,vincristine and prednison(cnop)is safe and effective in the treatment of diffuse large b cell lymphoma.patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if mitoxantrone hydrochloride liposome injection plus cyclophosphamide,vincristine and prednison(cnop)is safe and effective in the treatment of diffuse large b cell lymphoma.

Eligibility criteria:
inclusion criteria: * written informed consent prior to study specific screening procedures; * favorable index of curative effect of diffuse large b cell lymphoma confirmed by histological analysis; * ≥ 18 and ≤ 70 years of age, male or female; * advanced lymphoma and standard treatments failed; * may benefit from anthracycline-based drugs; * ecog performance status of 0-2; * more than 4 weeks from the last chemotherapy, more than 4 weeks from the last biotherapy, more than 4 weeks from the last clinical trial drug therapy; * life expectancy of more than 3 months; * sexually active women of childbearing potential must use a medically acceptable form of contraception; * adequate hepatic, renal, cardiac and hematologic functions: leukocyte≥3.5×10\^9/l,neutrophils≥2.0×10\^9/l,platelets≥100×10\^9/l, hemoglobin≥90g/l,creatinine clearance rate≤1.5×uln, serum bilirubin≤1.5×uln, alt≤2.5×uln(5×for liver metastasis),ast≤2.5×uln(5×for liver metastasis), alkaline phosphatase≤200 iu/l,electrocardiogram appeared to be essentially normal, ejection fraction of heart doppler ultrasound appeared to be normal. exclusion criteria: * pregnant or lactating women; * patients with multiple sclerosis; * suffering from serious internal disease, including serious heart attack, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension,uncontrolled infection, active peptic ulcer; * mitoxantrone has been used before; * the cumulative does of doxorubicin and epirubicin before inclusion have surpassed 360 mg/m2 and 600 mg/m2, respectively; * heart disease was caused after anthracycline-based drugs used; * other antineoplastic drugs need to be used in this study; * history of anthracycline-based drug allergy or liposome drug allergy; * uncontrolled primary brain tumor or brain metastases;
a study to evaluate the efficacy and safety of tl118 in solid tumors patients

Conditions: Solid Tumor

Summary: the main objective of the study will be to evaluate the efficacy of tl118 in participants with solid tumors harboring ntrk gene fusions

tl118 is an orally active inhibitor of the tropomyosin receptor kinase (trk) family consists of trka, trkb, and trkc. these receptors are encoded by the ntrk1, ntrk2 and ntrk3 genes, and oncogenic fusions of ntrk may cause cancer cells to grow and spread in the body. the purpose of this study is to explore how effective tl118 is for the treatment of patients with solid tumors harboring ntrk gene fusions.

Eligibility criteria:
inclusion criteria: 1. age 18 years old and above, male or female 2. histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an ntrk1/2/3 gene fusion that is predicted to translate into a fusion protein with a functional tropomyosin receptor kinase (trk)a/b/c kinase domain, without a concomitant second onco-driver 3. patients must have had disease progression during or after prior treatment for their tumor, or would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy or are not suitable - in the opinion of the investigator - to receive standard of care therapy; prior treatment with approved or investigational trk inhibitors is not allowed, except for prior trk treatment for less than 28 days due to intolerable toxicity) 4. at least one measurable lesion 5. eastern cooperative oncology group (ecog) score of 0, 1, or 2 6. a minimum life expectancy of \> 3 months 7. adequate bone marrow reserve, hepatic, renal, and coagulation function other inclusion criteria apply for participating in the study exclusion criteria: 1. any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \> 30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional chinese medicines (tcms) indicated for the tumor (including chinese patent medicine) within 2 weeks prior to enrollment 2. participation in another interventional clinical trial 2 weeks prior to enrollment or within 5 half-lives from the last dose of ip (whichever is shorter) 3. any unresolved toxicities from prior therapy greater than grade 1, at the time of screening with the exception of toxicities posing no safety risk in the opinion of the investigator 4. active central nervous system metastases 5. any other primary malignant tumors within 3 years (except for cured skin basal cell carcinoma and carcinoma in situ of cervix, low-risk cancer 6. any active infection which has not been controlled at screening other exclusion criteria apply for participating in the study

Keywords: oncology tl118 teligene cancer
hemostatic assessment of postpartum hemorrhage using sonoclot signature

Conditions: Postpartum Hemorrhage

Summary: postpartum hemorrhage is the leading cause of maternal morbidity and mortality throughout the world. rapid diagnosis and early management improve maternal prognosis. postpartum hemorrhage is defined by a blood loss exceeding 500 ml during the 24 h after delivery. there are many causes of postpartum hemorrhage. most cases develop from uterine atony, which accounts for 75% of cases. even though there are risk factors for postpartum hemorrhage, it is still an unpredictable obstetric emergency. coagulation plays an important role in postpartum hemostasis. primary and especially secondary coagulation disorders are risk factors for postpartum hemorrhage. when bleeding occurs, the decrease in fibrinogen levels is the most rapid change observed among markers of coagulation. recent studies show that fibrinogen concentration during the initial management of postpartum hemorrhage is the most informative biological marker for the severity of the hemorrhage. various methods are used to record coagulation profile. one of them is estimation by sonoclot. viscoelastic hemostatic assays devices (such as sonoclot) have practical advantages as point-of-care devices for monitoring major hemorrhage including a set of parameters that assesses a global coagulation profile like fibrinogen and platelet count. identification of coagulopathy by viscoelastic point-of-care testing can be helpful in guiding management of postpartum hemorrhage and preventing severe maternal outcomes.


Eligibility criteria:
inclusion criteria: 1. patients in childbearing period. 2. patients with bleeding occurring in the first 24 hours after delivery (primary postpartum hemorrhage). 3. patients with causes of postpartum hemorrhage like uterine atony, preeclampsia, blood diseases as inherited and prepartum acquired coagulopathies, and others e.g., acute fatty liver of pregnancy, amniotic fluid embolism, etc. exclusion criteria: 1. patients with bleeding after 24 hours from delivery (secondary postpartum hemorrhage). 2. patients with miscarriages (bleeding before 22 weeks of gestation) or antepartum hemorrhage. 3. traumatic causes of postpartum hemorrhage e.g., rupture uterus, abruptio placenta, lacerations, hematomas, uterine inversion, and iatrogenic trauma.
hr070803 in combination with oxaliplatin, 5-fluorouracil/lv versus gx as adjuvant therapy for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to look at the efficacy and safety of hr070803 in combination with 5 fluorouracil/leucovorin (5fu/lv) plus oxaliplatin compared to gemcitabine + capecitabine treatment as adjuvant therapy in patients with resected pancreatic cancer.

study design/ evaluation criteria main criterion: efficacy. the main criterion is the disease-free survival. disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. patients without event at the time of analysis will be censored at the date of last follow-up visit. secondary criteria include overall survival. os is defined as the time from date of randomization until the date of death from any cause. patients who are still living at the time of analysis will be censored at the date of last follow-up visit. secondary criteria also include 3-year disease-free survival rate/overall survival rate and 5-year disease-free survival rate/overall survival rate. tolerance patients evaluable for toxicity must have received one investigational drug.

Eligibility criteria:
inclusion criteria: 1. ecog performance status 0 or 1 2. histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (r0 and r1). 3. life expectancy of greater than or equal to 6 months. 4. full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery. 5. acceptable hematology parameters and blood chemistry levels. 6. able and willing to provide a written informed consent. exclusion criteria: 1. patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor; 2. presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma. 3. ca 19-9\> 180 u / ml within 21 days of registration on study. 4. prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma. 5. severe infection (\> ctcae grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment; 6. patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) patients with nyha class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.